Patients with colon adenocarcinoma (proximal to peritoneal reflection) in stage pT4a / b, N0-2, M0, or with primitive perforated tumor undergoing curative surgery. MedDRA version: 21.1 Level: PT Classification code 10055114 Term: Colon cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: OXALIPLATINO ACCORD - 5 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO IN VETRO DA 40 ML
Product Name: Oxaliplatino
Product Code: [Oxaliplatino]
Pharmaceutical Form: Concentra
Sponsors
FONDAZIONE IRCCS "ISTITUTO NAZIONALE DEI TUMORI"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) histopathologically confirmed intestinal-type, mucinous or signet ring cell adenocarcinoma of the colon (with upper limit of the tumor above the peritoneal reflection); 2) curative (microscopically complete) surgery performed by laparotomy or laparoscopy; 3) presence of at least one of the following risk factors for the development of metachronous PM: - primary tumor infiltrating the visceral peritoneum (pT4a, N0-2b, M0); - primary tumor directly invading adjacent organs (pT4b, N0-2b, M0); - perforated primary tumor (any T, N0-2b, M0); 4) age >18; 5) performance status =2 according to the WHO score 6) willingness to start adjuvant systemic therapy and post-operative follow-up; 7) signature of informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1) active sepsis; 2) impaired cardiac function (history of previous heart failure or 40% FE); 3) impaired renal function (serum creatinine >1.5 normal value or creatinine clearance 1.5 normal value); 5) impaired bone marrow function (leukocytes <4000/mm3, neutrophils <1500/mm3, platelets <80000/mm3); 6) impaired lung function (diagnosis of severe COPD or 50% FEV1 or 40% DLCO adjusted for age); 7) presence of extra-abdominal and/or hepatic metastases at CT scan of the chest, abdomen and pelvis with an intravenous contrast medium; 8) severe complications (grade 3-4) after primary cancer surgery; 9) haemorrhagic diathesis or coagulopathy; 10) pregnancy or lactation in progress; 11) psychiatric or neurological conditions that preclude the procedures of the protocol; 12) contraindications to laparoscopy; 13) known hypersensitivity to oxaliplatin or other platinum containing compounds and/or to any of their excipients; 14) history of previous malignancies treated in the last three years, excluding cutaneous spinocellular carcinoma and/or basocellular carcinoma; 15) prior pre-operative radio-chemotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective: of this study is to demonstrate the effectiveness of adjuvant PIPAC performed within 4-8 weeks after curative-intent surgery, and followed by adjuvant s-CT, in preventing the onset of PM in high risk colon cancer.;Secondary Objective: Secondary Objectives: are to assess feasibility, toxicity and impact on the quality of life (QoV) of the adjuvant PIPAC, performed in an early setting (within 4-8 weeks of primitive surgery), overall survival, disease-free survival (peritoneal and distant), and pattern of disease progression after the procedure;Primary end point(s): The efficacy of adjuvant PIPAC will be assessed by measuring peritoneal metastasis-free survival from the date of primary surgery to the date of MP diagnosis.;Timepoint(s) of evaluation of this end point: 30 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The adjuvant PIPAC performed in an early setting after primary surgery will be considered feasible if: •the laparoscopic procedure can be completed in 9 patients; •the postoperative stay will be three days or shorter in =6 patients; •the post-operative adjuvant s-CT will begin within 12 weeks of primary surgery in = 9 patients. The adjuvant PIPAC will be considered a well tolerated procedure if: •a maximum of one serious treatment-related complication will occur; •a maximum of one laparotomy conversion will occur; •a maximum of one hospital readmission will occur within 30 days. Overall survival will be measured from the date of primary cancer surgery to the date of death for any cause or, for patients still alive at the date of the last available follow-up (Kaplan-Meier). Disease-free survival will be measured from the date of primary cancer surgery to the date of MP diagnosis, systemic metastases or patient death. The pattern of disease recurrence after adjuvant PIPAC will be determined by recording the anatomical site and date of onset of both metacrone MP, as well as metacrone systemic metastasis (extraperitoneal), and deaths. QoV will be evaluated with EORTC QLQ-C30 and EORTC QLQ-CR29 questionnaires;Timepoint(s) of evaluation of this end point: 30 months | — |
Countries
Italy
Contacts
Public ContactClinical Trial Center
Fondazione IRCCS Istituto Nazionale dei Tumori
Outcome results
None listed